Refractory MSI - H Solid Tumors Prior of PD-(L) 1 TherapyPhase 2NCT03607890

Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

A Phase 2 study testing Nivolumab and Relatlimab in people with Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy and MSI-H Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy, MSI-H Tumors
What is being tested?: Nivolumab and Relatlimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 2 sitesUnited States
Study dates: 16 Nov 2018to Oct 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
Patients must have received prior PD-1/PD-L1 inhibitor therapy
Patients with the presence of at least one measurable lesion.
Life expectancy of greater than 3 months.

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Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
Documented left ventricular ejection fraction (LVEF) ≥ 50% - 6 month prior to drug administration.
Must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.

Who cannot join

Known history or evidence of brain metastases.
Require any antineoplastic therapy.
History of prior treatment with anti-LAG3.
Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
Had any investigational cytotoxic drug within 4 weeks prior to study treatment.
Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.

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Major surgery
Hypersensitivity reaction to any monoclonal antibody.
Has an active known or suspected autoimmune disease.
Has a diagnosis of immunodeficiency.
Prior tissue or organ allograft or allogeneic bone marrow transplantation.
Requires daily supplemental oxygen
History of interstitial lung disease.
Significant heart disease
History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
Infection with HIV or hepatitis B or C at screening.
Has an active infection.
Unable to have blood drawn.
Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
Woman who are pregnant or breastfeeding.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Cedars Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

Conditions: Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy, MSI-H Tumors
Being tested: Nivolumab, Relatlimab
Keywords: Relatlimab, Nivolumab, Immunotherapy, Anti - PD-1, Anti - LAG-3, Antibodies, MSI, MMR deficient, Microsatellite instability
Medical subject headings: Turcot syndrome, Microsatellite Instability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabDrug
Also called anti-PD-1, OPDIVO
Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
RelatlimabDrug
Also called BMS-986016
Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
NivolumabDrug
Also called anti-PD-1, OPDIVO
Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
RelatlimabDrug
Also called BMS-986016
Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
NivolumabDrug
Also called anti-PD-1, OPDIVO
Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
RelatlimabDrug
Also called BMS-986016
Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).

Study groups in NCT03607890
Study group	Role	What they receive
Cohort 1: Nivolumab and Relatlimab	Experimental	480mg/160mg (co-administered) Receives: Drug: Nivolumab; Drug: Relatlimab
Cohort 2: Nivolumab and Relatlimab	Experimental	480mg/960mg or 480mg/160mg (sequential administration) Receives: Drug: Nivolumab; Drug: Relatlimab
Cohort 3: Nivolumab and Relatlimab	Experimental	480mg/480mg (sequential administration) Receives: Drug: Nivolumab; Drug: Relatlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: 4 years

Secondary outcomes (1)

Number of participants experiencing study drug-related toxicities
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 2018Oct 2027

First posted31 Jul 2018
Study start16 Nov 2018
Primary completionOct 2027 (estimated)
Study completionOct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Refractory MSI - H Solid Tumors Prior of PD-(L) 1 TherapyStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03607890
Sponsor's protocol ID: J18102
Other IDs: IRB00173534, P50CA062924
Status last verified: Oct 2026
First submitted: 24 Jul 2018
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
ClinicalTrials.gov ID: NCT03607890
Acronym / sponsor ID: J18102
Conditions: Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy, MSI-H Tumors
Keywords: Relatlimab, Nivolumab, Immunotherapy, Anti - PD-1, Anti - LAG-3, Antibodies, MSI, MMR deficient
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 38 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: Bristol-Myers Squibb, National Cancer Institute (NCI)
Study start: 16 Nov 2018 (actual)
Primary completion: Oct 2027 (estimated)
Study completion: Oct 2027 (estimated)
First posted: 31 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1: Nivolumab and Relatlimab	Experimental	Drug: Nivolumab, Drug: Relatlimab480mg/160mg (co-administered)
Cohort 2: Nivolumab and Relatlimab	Experimental	Drug: Nivolumab, Drug: Relatlimab480mg/960mg or 480mg/160mg (sequential administration)
Cohort 3: Nivolumab and Relatlimab	Experimental	Drug: Nivolumab, Drug: Relatlimab480mg/480mg (sequential administration)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
Patients must have received prior PD-1/PD-L1 inhibitor therapy
Patients with the presence of at least one measurable lesion.

Key exclusion criteria (21 listed)

Known history or evidence of brain metastases.
Require any antineoplastic therapy.
History of prior treatment with anti-LAG3.
Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
Had any investigational cytotoxic drug within 4 weeks prior to study treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NivolumabAlso: anti-PD-1, OPDIVOPatients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).	Drug	Cohort 1: Nivolumab and Relatlimab
RelatlimabAlso: BMS-986016Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).	Drug	Cohort 1: Nivolumab and Relatlimab
NivolumabAlso: anti-PD-1, OPDIVOPatients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).	Drug	Cohort 2: Nivolumab and Relatlimab
RelatlimabAlso: BMS-986016Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).	Drug	Cohort 2: Nivolumab and Relatlimab
NivolumabAlso: anti-PD-1, OPDIVOPatients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).	Drug	Cohort 3: Nivolumab and Relatlimab
RelatlimabAlso: BMS-986016Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).	Drug	Cohort 3: Nivolumab and Relatlimab

Primary outcome

Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: 4 years

1 secondary outcome

Number of participants experiencing study drug-related toxicities
Time frame: 4 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dung Le, MD principal investigator

Johns Hopkins Medical Institution

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03607890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.